# Core 2: Bioinformatics and Biostatistics

> **NIH NIH P01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2024 · $239,846

## Abstract

This Program Project comprises four individual projects, which propose to: implement and test imaging, pathology, and
molecular biomarkers to optimize treatment switching within the I-SPY2.2 sequential multiple assignment randomized
trial (SMART) adaptive framework (Project 1); refine non-invasive imaging metrics to optimize early treatment switching
decisions and prognostic modeling of long-term outcomes (Project 2); characterize of the biology of non-responders using
imaging and molecular analysis to inform treatment (Project 3); and develop and optimize of a portfolio of agents that
matches biology of patients within the I-SPY2.2 framework (Project 4). The Bioinformatics and Biostatistics Core will act
as a centralized dedicated team where the analytical goals of these projects converge. We will work closely with each of
the project teams to develop project-specific analysis plans and provide analytical support. We will develop novel
statistical methodologies for the complex trial designs and build predictive models across multiple modalities (imaging,
pathology, molecular profiles and their combination). Our goal is to facilitate cross-project interactions to refine robust
decision algorithms to optimize adaptation of treatment for individual women based on their response within the I-SPY
2.2 trial according to the quality standards necessary to evaluate experimental regimens within a regulatory evidence
generation framework.
Specifically, the Bioinformatics and Biostatistics Core has three aims:
Specific Aim 1: To provide innovative bioinformatics and statistical modeling and analytical approaches needed by the
projects to achieve their Specific Aims.
Specific Aim 2: To develop SMART methods that incorporate quality of life and residual cancer burden measures into
the I-SPY2.2 Program Project framework (Project 1, Aim 3).
Specific Aim 3: To synthesize biomarker and drug response data within and across projects into actionable clinical
information for implementation in I-SPY2.2.

## Key facts

- **NIH application ID:** 10880549
- **Project number:** 5P01CA210961-07
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Christina Yau
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $239,846
- **Award type:** 5
- **Project period:** 2017-09-08 → 2028-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10880549

## Citation

> US National Institutes of Health, RePORTER application 10880549, Core 2: Bioinformatics and Biostatistics (5P01CA210961-07). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10880549. Licensed CC0.

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